9 results
·
28ms
·
Sources: EU EUDAMED, US FDA
E-PAIN CARE
FDA 510(k)
FDA Class 2
·General Hospital
Paliney®
FDA UDI
Dentsply International Inc.·D00110417140·Triple Thick Rod
MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149
FDA 510(k)
FDA Class 2
·Anesthesiology
BIPAP PRO BI-LEVEL SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 8, 2013
BIOLOX DELTA
FDA Adverse Event
BIOMET·Product code LZO·April 4, 2011
VITALITY AVT FAST-CHARGE
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015